MAUDE Adverse Event Report: WRIGHT MEDICAL TECHNOLOGY INC VALOR NAIL SM LT 11.5MMX150MM; SCREW, FIXATION, BONE

Catalog Number	415101115L
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The sales rep reported that "following installation of a valor range nail, i declare an anomaly on the implant in question, which was nevertheless fitted and implanted.The compression screw was never able to engage and perform its compression action.This caused a blockage when the posterior and subtalar screws were inserted".A surgical delay of 30 minutes was reported.
Additional Manufacturer Narrative
The device will not be returned.If additional information becomes available, it will be provided in a supplemental report.
Additional Manufacturer Narrative
The complaint couldn't be confirmed, since the device was not returned for evaluation and no other evidences were provided.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If the device is returned or if any additional information is provided, the investigation will be reassessed.
Event or Problem Description
The sales rep reported that; "following installation of a valor range nail, i declare an anomaly on the implant in question, which was nevertheless fitted and implanted.The compression screw was never able to engage and perform its compression action.This caused a blockage when the posterior and subtalar screws were inserted".A surgical delay of 30 minutes was reported.

• Brand Name: VALOR NAIL SM LT 11.5MMX150MM
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): WRIGHT MEDICAL TECHNOLOGY INC; 1023 cherry rd; memphis TN 38117
• Manufacturer (Section G): WRIGHT MEDICAL TECHNOLOGY, INC.; 11576 memphis arlington rd; arlington TN 38002
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 19772716
• Report Number: 3010667733-2024-00447
• Device Sequence Number: 8111022
• Product Code: HWC
• UDI-Device Identifier: 00840420125569
• UDI-Public: 00840420125569
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 415101115L
• Device Lot Number: 1730427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/24/2024
• Supplement Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown